Events

Retiro De Equipo (Recall) de FUJIFILM General X-ray System FDR Smart f series

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fujifilm Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00351-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00351-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Fujifilm has identified that fdr smart f systems should have been sold and installed with the stated condition of:“operation in the shielded room over 20 db radiated emission attenuation”. the units have been sold with no such condition being stated.
  • Acción
    Fujifilm are advising service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures. Correction will include the addition of ferrite cores, cable shielding and replacement of internal hardware and a firmware update.

Device

FUJIFILM General X-ray System FDR Smart f series
  • Modelo / Serial
    FUJIFILM General X-ray System FDR Smart f seriesARTG Number: 197063Fujifilm Australia - X-ray system, diagnostic, general-purpose, stationary, analogue
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd